BC BIOMEDICAL SA-2600 (01) PDF DOCUMENT

Use: The BC BIOMEDICAL SA-2600 is intended for testing only and should never be used in diagnostics, treatment, or any other capacity where it would come in contact with a patient.

Connections: All connections to patients must be removed before connecting the Device Under Test (DUT) to the SA-2600. A serious hazard may occur if the patient is connected when testing. Do not connect any leads from the patient directly to the SA-2600 or DUT while it is powered by the SA-2600.

Modifications: The SA-2600 is intended for use within the published specifications. Any application beyond these specifications or any unauthorized user modifications may result in hazards or improper operation.

Liquids: Do not submerge or spill liquids on the SA-2600. In the event of a spill, do not operate the device regardless of the fluid type.

Voltage: When the SA-2600 is in Lead Isolation mode, 110% of line voltage is applied to the Patient lead connectors and/or External test leads. Although this voltage is applied through an internal current limiting resistance of 121 kΩ, do not touch the test leads, connections, or DUT while the ISO button is highlighted.

Usage: The BC BIOMEDICAL SA-2600 is not a continuous duty device. It is intended for short duration testing within the specified current limits and duty periods. Do not leave the DUT connected for extended time periods. Do not drop the SA-2600.

Environment: Exposure to environmental conditions outside the specifications can adversely affect performance. Allow the SA-2600 to acclimate to specified conditions for at least 30 minutes before operating it.

Inspection: The SA-2600 should be inspected before each use for obvious signs of abuse or wear. It should not be used and should be serviced if any parts are in question.

Service: The SA-2600 is intended to be serviced only by authorized service personnel. Troubleshooting and service procedures should only be performed by qualified technical personnel.

Fuse: Only replace the SA-2600 fuse with the specified type and rating.

To ensure the accuracy of the BC BIOMEDICAL SA-2600, it is recommended that it be calibrated at least once every 12 months. Calibration must be done by qualified personnel.

First, disconnect Line Power to the BC BIOMEDICAL SA-2600 before attempting to clean it. Do not immerse the device. The SA-2600 should be cleaned by wiping gently with a damp, lint-free cloth. A mild detergent can be used if desired.

General Features:

• 4.3″ LCD COLOR TOUCH DISPLAY

• AUDIO FEEDBACK

• TOUCH CONTROL KEYS – NO KNOBS

• 10 UNIVERSAL PATIENT LEAD INPUTS

• HIGH IMPACT PLASTIC CASE

• CUSTOMIZABLE AUTOSEQUENCES

• FIXED GENERIC AUTOSEQUENCES

Safety Analyzer Features:

• LINE VOLTAGE MEASUREMENT

• DEVICE UNDER TEST CURRENT MEASUREMENT

• EARTH / GROUND LEAD RESISTANCE

• EARTH / GROUND LEAKAGE CURRENT

• ENCLOSURE / CHASSIS LEAKAGE CURRENT

• PATIENT LEAD TO LEAD LEAKAGE CURRENT

• PATIENT LEAD TO EARTH / GROUND LEAKAGE CURRENT

• PATIENT ISOLATION LEAKAGE CURRENT

• POINT TO POINT RESISTANCE

• POINT TO POINT LEAKAGE CURRENT

• TRUE RMS MEASUREMENTS

• AAMI ES1-1993 or IEC 60601 SELECTABLE TEST LOADS

• 90 TO 264 VAC OPERATION

• 20 AMP RATING (SA-2600 and SA-2600-INTL Models)

• 10 AMP RATING (SA-2600-AUS Models)

• SELF TEST POINTS

• EXTERNALLY REPLACEABLE GROUND FUSE

• ECG: 30, 60, 120 AND 240 BPM

• SINE: 10, 60 AND 100 Hz

• SQUARE: 0.125 AND 2.0 Hz

• TRIANGLE: 2 Hz

• HIGH LEVEL OUTPUT (1 V p-p)

• AMPLITUDE ACCURACY: +/- 2%

• FREQUENCY ACCURACY: +/- 0.5%

• SA-2600: Standard model with hospital-grade NEMA 5-15P line plug and hospital-grade NEMA 5-20R DUT test receptacle for use in the US and other compatible countries.

• SA-2600-INTL: International model with an IEC C20 receptacle pigtail (requires a country-specific line cord) and a universal DUT test receptacle compatible with various international plugs.

• SA-2600-AUS: Australian model with an AU1-10P line plug and AU1-10R DUT test receptacle for use in Australia/New Zealand and other compatible countries.

The BC BIOMEDICAL SA-2600 has four keys that allow manual control of the power connections to the DUT: HOT, NEUTRAL, GROUND, and POLARITY.

The unit will power up with the Hot Open, Neutral Closed, and Ground Closed, and in Forward Polarity. It is recommended that the unit be returned to this condition when plugging and unplugging the DUT.

The Forward/Reverse Polarity key has a safety delay feature. When pressed, the DUT power is disabled, a delay is activated, and then the internal relays switch the polarity and reapply power. This delay allows any reactive power in the DUT to discharge before polarity is reversed.

The BC BIOMEDICAL SA-2600 has two snaps on the side of the unit for a quick self-test. They provide a fixed 1.0 Ohm resistance to Earth/Ground and a 100 μAmp leakage current source to Earth/Ground.

To use them, apply the Chassis lead to the appropriate snap and set the Analyzer to either Earth Resistance or Enclosure Leakage mode to verify the reading.

Note: The fixed 1.0 Ohm resistance Self-Test Snap is measured without a Zero Offset applied.

Once the BC BIOMEDICAL SA-2600 is plugged in, the first step is to ensure the wall receptacle is wired properly (for Non-Isolated Power Systems Only). The status of the receptacle is displayed at the top of the Home Screen and the Mains Voltage Screen. There are 3 different Outlet Statuses:

Note: These statuses are only applicable for 120V Non-Isolated Power systems.

Mains Voltage: From the home screen, select “Mains/Line Voltage”. The screen will display the voltage present on the incoming power lines, measured from Line to Neutral. Ensure this value is within the DUT’s specifications.

Device Current: From the home screen, select “Device Current”. The screen will display the current draw of the DUT. For this test, the receptacle should be configured with HOT-CLOSED, NEUTRAL-CLOSED, GROUND-CLOSED and POLARITY-FWD.

Earth Resistance:

1. From the home screen, select “Earth Resistance”.

2. Plug the Chassis Test lead into the Chassis Connector on the SA-2600.

3. Connect the other end of the lead to a solid ground point on the DUT.

4. The screen will display the resistance between the Chassis Test lead and the Receptacle Earth/Ground. The DUT power cord should be plugged into the SA-2600 receptacle for this test.

Zeroing Leads: To zero the test leads for an accurate reading, use the provided Ground Pin Adapter to connect the chassis cable to the ground pin of the SA-2600 receptacle. Tap the “Zero Leads” button. An asterisk (*) will appear above the ohm symbol to indicate an offset is being applied.

Point to Point Resistance:

1. Remove the DUT power cable from the SA-2600 receptacle.

2. Plug a Chassis cable into the Chassis port and a second Chassis cable into the external connector.

3. The display will read the resistance between the two cables when they are connected to the points of interest.

From the home screen, select “Leakage Modes”. On this screen, you can select the test mode and, where applicable, the patient lead. You can also select between AAMI ES1-1993 or IEC 60601 test loads.

• Earth/Ground Leakage Current: In this mode, the display shows the leakage current in the ground wire of the DUT.

• Enclosure Leakage: This mode displays the leakage current between the Enclosure (Chassis) and Earth/Ground. The Chassis Test lead must be connected to a solid ground point on the DUT. For a non-conductive enclosure, a 200 cm² conductive foil pad should be used.

• Lead to Earth Leakage: This mode displays the leakage current between a selected patient lead and Earth/Ground. Attach the patient leads and use the arrow keys to select an individual lead or all leads.

• Lead to Lead Leakage: This mode displays the leakage current between the selected Patient Lead and all other patient leads. Attach the patient leads and use the arrow keys to select an individual lead.

• Lead Isolation (MAP): This mode tests the leakage current between the selected Patient Lead(s) and Earth/Ground when 110% of line voltage is applied. Use the arrow keys to select a lead, then press the “Isolation Voltage” On/Off switch to apply the voltage and take the reading. A warning is associated with this test due to the applied voltage.

• Point to Point Leakage Current: This mode shows the leakage current between the Chassis Test Lead and the External Test Lead. The leads must be plugged into their respective connectors and attached to the points of interest on the DUT.

From the home screen, select “ECG Waveforms”. On this screen, use the Mode arrow keys to select the desired waveform and the Frequency arrow keys to change the frequency where applicable.

The available waveforms are:

• NSR Pulse: Simulates a Normal Sinus Rhythm pulse at 30, 60, 120, and 240 BPM.

• Sine: Sends out Sine waves of selectable frequency – 10, 60, and 100 Hz.

• Square: Sends out Square waves of selectable frequency – 0.125 and 2 Hz.

• Triangle: Sends out Triangle waves of frequency 2 Hz.

1. From the home screen, press the “Autosequences” button.

2. Select one of the three “Custom Sequence” options to edit. You can also view, but not edit, the fixed generic Autosequences (e.g., NFPA-99).

3. Set the “DUT Line Power Mode”. Select “ON” for devices that automatically power on, or “STANDBY” for devices that require a power button press. In STANDBY mode, the sequence will pause to allow the operator to turn on the DUT.

4. Tap on the sequence name at the top to rename it.

5. Press the dots next to each test (e.g., Earth Resistance, Leakage, ECG Waveforms) to enable or disable it for the sequence. A red dot indicates at least one sub-test is enabled.

6. Tap on the test name (e.g., “Leakage”) to configure its specific options, such as which leads to test and the pass/fail limits (0 – 2000 uA).

7. In the “Test Settings” section, you can set a “Measurement Delay after DUT Power On” (0-255 seconds), select the “Test Load” (AAMI or IEC), and choose to “Repeat Autosequence after DUT Power toggle”.

8. When finished, press the back arrow to save or the next arrow to save and run the sequence.

1. From the Autosequence menu, select the desired sequence to run.

2. Double-check that all desired tests and limits are correctly configured.

3. Tap the “next” arrow in the top right to navigate to the DUT Information screen. You can enter information like Asset ID, Manufacturer, etc., for tracking purposes (this is optional).

4. Tap “Proceed to Test”.

5. If the Earth Resistance test is enabled, you will be prompted to zero the test leads. Connect the chassis cable to the ground pin adapter and tap the “Zero Leads” button.

6. The next screen is the “Configure Test Setup” screen. Connect all applicable cables to the DUT, including the power cord, chassis cable, and any patient leads. Tap the “next” arrow when ready.

7. The Autosequence will begin, starting with Mains Voltage, Earth Resistance (if enabled), and Device Current. It will then proceed through the selected leakage and ECG tests.

8. For ECG tests, user input is required to select pass/fail based on the DUT’s display of the waveform.

9. You can tap the “Stop” button at any point to exit the sequence and go to the results screen.

After an Autosequence is complete or has been stopped, the “AutoSequence Test Summary” screen is displayed.

• The screen shows summary results for Mains/Line Voltage, Device Current, and Earth Resistance.

• In the “Leakage Results” section, buttons for each test mode (Earth/Ground, Lead to Earth, etc.) are shown. A button will be red if a test failed, white if all tests passed, and grayed out if no tests in that mode were run.

• Tap on a specific leakage test button to see a detailed view of all measurements taken in that mode. Failed readings will be highlighted in red.

• Tap the “ECG Results” button to see a detailed view of the pass/fail results for each waveform test.

• Tap the “DUT Information” button to review the information that was entered before the test began.

Press the cog symbol on the bottom left of the Main Screen to access the Settings screen. From there, you can access the following settings by pressing the icons at the bottom of the screen:

• Screen Brightness: Adjust the brightness from 1 to 10 using the “+” and “-” buttons.

• Date and Time: Select the Date or Time tab. You can change the date format (MM/DD/YYYY or DD/MM/YYYY) and set the date. You can also change the time format (12 HR or 24 HR) and set the time.

• Communication: Change the remote connection mode between “Bluetooth” (for connecting to the myBC Mobile app) and “USB” (for connecting to a PC).

You can also toggle the “Outlet Status” display ON or OFF from the main settings screen. Since the Outlet Status is for 120V Non-Isolated Power systems only, it can be disabled if not applicable.

MAINS VOLTAGE

DEVICE CURRENT

EARTH RESISTANCE

LEAKAGE CURRENT

PHYSICAL & ENVIRONMENTAL